Skip to main content
OpenTrials
Completed

NCT Number: NCT02082379

In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route

We hypothesize that infant and children will show different levels of acceptance of different interfaces while they receive inhaled therapy.

We also hypothesize that children will exhibit different amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 week–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

About this study

Aerosol medicine is widely used in treating pulmonary diseases in children. Delivering drugs via aerosol faces several challenges; some are related to the drug and the delivery methods and others to the patient behavior. The latter are crucial and can significantly affect the lung deposition of the drug. Infants are known to be obligate nose breathers making the transnasal route the natural approach for drug delivery in this age group. Different interfaces are already available in the market and are specifically designed to be used in children to improve the child acceptability of the interface and by the result to improve drug deposition. Due to limitations in the use of radiolabeled aerosols and pharmacokinetics/pharmacodynamics studies in infants and children, in-vitro models were developed. These models still lack biological variability which leads to overestimating lung deposition. So, real life correction factors are needed to improve current in-vitro modeling. Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.

Our objectives are to provide real life data of acceptance of different interfaces by infants and children and to provide a real life correction factor to improve current in-vitro modeling.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born at term
  • Healthy
  • Pacifier user
  • Newborn 1-6 week old
  • Infants 6-8 month old

Exclusion criteria

  • Chronic respiratory disease
  • Cardiac disease
  • Prematurity
  • Neurological disease
  • Allergy to Normal Saline
  • Allergy to any components of the interfaces

Treatment and study plan

inhaled normal saline using different interfaces.

Behavioral

A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The infants will be videotape while they receive inhaled aerosol, and sound will be captured. The camera will be positioned so the face of the parent holding the child will not be visible.

Primary outcomes

  1. Acceptance of different interfaces while they receive inhaled therapy

    Time frame: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization

    The recordings will be analyzed by the 2 investigators for acceptance of the patient of the interface (likert scale 1 to 5: 5= Complete acceptance, 4= Accepting most of the time, 3= Accepting/rejecting half of the time, 2= Rejecting most of the time, 1= Complete rejection). The data will be expressed as average of value assigned by each of the 2 researchers. Analysis of variance for repeated measures followed by Tukey test will be used to compare the 2 endpoints. A p value < 0.05 will be considered statistically significant

Secondary outcomes

  1. Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery

    Time frame: during the 3 minutes of nebulization

    The recordings will be analyzed by the 2 investigators for percentage of time spent with aerosol aligned with the patient nostrils when using different interfaces

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2014
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.